Intended Use; Contraindications; Operating Environment - Flaem Rf9 Bedienungsanleitung

Aerosol therapy accessories
These operating instructions are provided for device model RF9-1, consisting of the nebuliser
(B2) and relevant accessories (B1, B3 - B10).
The RF9 nebuliser may be combined with: a Flaem compressor unit, non Flaem compressor
unit, centralised compressed air systems; in the latter two cases the working pressure must
fall within the range of the values set out in the table in the section NEBULISER TECHNICAL
SPECIFICATIONS provided below in the manual.

INTENDED USE

Medical device for the administration of medication through inhalation, with inhalation therapy and
medication prescribed by a Doctor.
INDICATIONS FOR USE
Treatment of respiratory diseases. Medications must be prescribed by a doctor who has assessed the
patient's general condition.

CONTRAINDICATIONS

• The medical device should NOT be used for patients who are unable to breathe on their own or
who are unconscious.
• Do not use the device in anaesthetic or assisted ventilation circuits.
INTENDED USERS
The device is intended for use by legally authorised medical personnel/health workers (doctors,
nurses, therapists, etc.). The device can be used directly by the patient.
TARGET GROUP OF PATIENTS
Adults, children of all ages, infants. Before using the device, the user manual must be read carefully
and an adult responsible for safety must be present if the device is used by infants, children of
any age or persons with limited abilities (e.g. physical, mental or sensory). It is up to the medical
personnel to assess the patient's condition and capabilities in order to determine, when prescribing
therapy, whether the patient is able to operate the aerosol safely on their own or whether the
therapy should be administered by a responsible person.
Please refer to medical personnel for the evaluation of the use of the device on particular types of
patients such as pregnant women, lactating women, infants, incapacitated persons or persons with
limited physical capabilities.

OPERATING ENVIRONMENT

This device can be used in healthcare facilities, such as hospitals, outpatient clinics, etc., or even at
home.
WARNINGS CONCERNING POSSIBLE MALFUNCTIONS
• Should your device fail to perform, please contact the authorised service centre for clarifications.
• The manufacturer should be contacted to report problems and/or unexpected events relating to
operation and if necessary for clarification of use and/or maintenance/hygienic preparation.
• Please also refer to the troubleshooting section.
WARNINGS
• Use the device only as a therapeutic inhaler. This medical device is not intended as a life-saving
device. Any other use is considered improper and can be dangerous. The manufacturer is not liable
for any improper use.
• Always consult your general practitioner for identification of treatment.
• Follow the instructions of your doctor or respiratory rehabilitation therapist regarding the type of
medicine, dosage and treatment indications.
• If you should experience allergic reactions or other problems while using the device, stop using it
immediately and consult your doctor.
• Keep this manual safe for further reference.
• If the packaging is damaged or opened, contact the distributor or service centre.
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